BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN

    MDR report key: 6906652 · Received October 2, 2017

    Report

    Report Number
    6906652
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 29, 2017
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TUBING WITH YELLOW CLAMP IS LEAKING WHERE THE TUBING GOES INTO THE FILTER. MANUFACTURER RESPONSE FOR TRIFURCATED SWAN-LOCK EXTENSION SET WITH FILTER AND SWAN LOCK EXTENSION SET WITH FILTER, (BRAND NOT PROVIDED) (PER SITE REPORTER): EMAIL TO REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687837 CODAN SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION BC 248

    Patients

    Seq Age Sex Outcome Treatment
    1